Device recall
Z-1148-2013: IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog…
FDA device recall · Class III · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-1148-2013 |
|---|---|
| Recall event | 64790 |
| Product | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious… |
| Product code | KTN |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 29, 2013 |
| 510(k) numbers | K042272 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database